Randomised Comparison of 2 Cold Snare Polypectomy Techniques

Bowel Cancer Clinical Trial

Official title:

A Prospective Randomised Comparison of Cold Snare Polypectomy Versus Cold Snare Pseudosuction Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208401
• Other study ID #: STH17227
• Status: Completed
• Phase: N/A
• First received: July 30, 2014
• Last updated: August 12, 2014
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: National Research Ethics Service
• Study type: Interventional

Clinical Trial Summary

Different modalities are employed to remove small colonic polyps which potentially harbour a cancer risk. But, they can all vary in their completeness of removal, safety and the histological quality and the gold standard technique has yet to be defined. A novel suction pseudopolyp technique has been described by Patullo et al and in their prospective study, 126 polyps measuring less than 10mm flat or sessile were removed by this method with 100% complete endoscopic resection and without any immediate or delayed complications. The aim of the investigators study is to compare this technique with the standard cold snare technique. Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size will be eligible and they will be randomised to the polypectomy technique. Patient demographics and polyp characteristics will be recorded. The primary outcome measured will be the macroscopic resection rate. The secondary outcome measures are abdominal pain, tenderness, bleeding and fever.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with small polyps 3-7 mm in size, flat or sessile found during colonoscopy

Exclusion Criteria:

• Patients are less than 18 years old

• Pregnant

• Inadequate bowel preparation

• On anticoagulants or clopidogrel

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Cancer

Intervention

Procedure:
• conventional cold snare polypectomy
conventional cold snare polypectomy
• Cold snare polypectomy with suction
Cold snare polypectomy with suction

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete macroscopic polyp eradication rate	The primary outcome for this study is the polypectomy completion rate. This will be assessed both macroscopically and histologically. The analysis for statistical difference between the 2 techniques and abdominal symptoms will be compared by the Chi2 test for categorical data.	At time of polypectomy intervention	No